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CompletedNCT02963571Updated Nov 15, 2016

Posterior Percutaneous Pedicle Screw Fixation for Acute Thoracolumbar Vertebral Fractures

An interventional study of posterior percutaneous pedicle screw internal fixation in Vertebral Fracture, sponsored by 153rd Hospital of Chinese People's Liberation Army. Completed. Open to participants aged 25 Years to 47 Years. Per ClinicalTrials.gov, last updated 2016-11-15.

Sponsored by 153rd Hospital of Chinese People's Liberation Army · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
25 Years to 47 Years
Sex
All
01

Study summary

To validate the safety and effectiveness of minimally invasive posterior percutaneous pedicle screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column injury.

Read the detailed description

History and current related studies Thoracolumbar spinal fractures are frequently seen after trauma because of the biomechanical transitional junction of this structure. The primary treatment method used for traumatic thoracolumbar spinal fracture is posterior pedicle screw fixation, but this method has some disadvantages including severe trauma, extensive bleeding, long rehabilitation time, and long postoperative duration of intractable lumbar stiffness and low back pain. These complications occur mainly because of wide stripping and injury of the paraspinal muscles and peri-articular denervation. Percutaneous pedicle screw external fixation of spine fracture can reduce injury caused by screw insertion into the paraspinal muscles, particularly in the treatment of acute thoracolumbar vertebral compression fracture with simple anterior spinal column injury.

Adverse events We recorded possible adverse events, including wound pain, infection, back muscle pain, spinal cord/nerve injury, screw pull-out, or screw loosening. If severe adverse events occurred, details including the data of occurrence and measures taken to treat the adverse events were reported to the principle investigator and the institutional review board within 24 hours.

Possible biases and management measures Possible biases

  • Diagnosis bias
  • Admission rate bias (hospitalized patients were preferred to reduce loss to follow-up and to increase compliance)
  • No response bias (subjects not responding to the questionnaire or not responding truthfully)
  • Mixed bias (sex and age) Measures taken to control possible biases
  • Formulation of strict inclusion and exclusion criteria
  • Ensuring sample independence
  • Discussion of the mixed factors that may potentially influence the curative effects, such as pathological factors, course of disease, and sex

Statistical analysis Statistical analysis was performed by a statistician using SPSS 19.0 software (IBM, Amrok, USA), and was conducted following the intention-to-treat principle. Normally distributed measurement data were expressed as the mean ± SD, and minimums and maximums. Non-normally distributed measurement data were expressed as lower quartile (q1), and median and upper quartile (q3). The Wilcoxon matched-pairs signed-ranks test was performed for comparison of the Cobb angle before surgery with the Cobb angle 3 years after surgery, and the McNemar's chi-squared test was used to compare the incidence of adverse reactions. The significance level was α = 0.05.

02

Conditions studied

  • Vertebral Fracture
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 32 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

This is the only study on the registry with 153rd Hospital of Chinese People's Liberation Army as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 47 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Meet the diagnostic criteria of acute thoracolumbar vertebral fracture with simple anterior spinal column injury as confirmed by radiography, CT and MRI
  • AO classification type A
  • Thoracolumbar injury severity score of 4-5 (Park et al., 2016)
  • Traumatic fracture
  • Age 25-47 years

Exclusion criteria

Exclusion Criteria:

  • Fracture complicated by spinal cord injury
  • Fracture complicated by nerve injury
  • Refusal to provide informed consent
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    screw fixation

    The patients underwent minimally invasive posterior percutaneous pedicle screw internal fixation.

    Procedure: posterior percutaneous pedicle screw internal fixation

Interventions

  • Procedureposterior percutaneous pedicle screw internal fixation

    The patients underwent minimally invasive posterior percutaneous pedicle screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column injury.

06

What researchers measure

Primary outcomes

  1. The Cobb angle of the injured vertebral body

    To investigate the change in the thoracolumbar spine curvature. A greater Cobb angle indicates more severe kyphosis.

    Time frame: before, immediately after, and 3 months after surgery

Secondary outcomes

  1. Anterior height of the injured vertebral body

    To evaluate the morphological recovery of the thoracolumbar spine. A smaller anterior height of the injured vertebral body indicates less severe injury to the vertebral body.

    Time frame: before, immediately after, and 3 months after surgery

  2. X-ray

    Time frame: before, immediately after, and 3 months after surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02963571
Lead sponsor
153rd Hospital of Chinese People's Liberation Army
Responsible party
Lei Liang (Attending Physician, 153rd Hospital of Chinese People's Liberation Army) — Principal investigator
First posted
Nov 15, 2016
Start date
Aug 2010
Primary completion
Dec 2011
Completion
Jun 2014
Last update
Nov 15, 2016

Study contacts

Lei Liang, Master
principal investigator · PLA 153 Central Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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